BREO ELLIPTA Drug Patent Profile

When do Breo Ellipta patents expire, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-five patent family members in twenty-nine countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $2.0bn, indicating a strong incentive for generic entry (peak sales were $2.8bn in 2021).

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BREO ELLIPTA

International Patents:	135
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	50
Patent Applications:	71
Drug Prices:	Drug price information for BREO ELLIPTA
Drug Sales Revenues:	Drug sales revenues for BREO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREO ELLIPTA
What excipients (inactive ingredients) are in BREO ELLIPTA?	BREO ELLIPTA excipients list
DailyMed Link:	BREO ELLIPTA at DailyMed

See drug prices for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BREO ELLIPTA

Constraining patent/regulatory exclusivity:

11,116,721*PED

NDA:

204275

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
GlaxoSmithKline	PHASE4
Theravance Biopharma	PHASE4

See all BREO ELLIPTA clinical trials

Pharmacology for BREO ELLIPTA

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BREO ELLIPTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREO ELLIPTA	Powder for Inhalation	fluticasone furoate; vilanterol trifenatate	100 mcg/25 mcg	204275	1	2025-06-16

US Patents and Regulatory Information for BREO ELLIPTA

BREO ELLIPTA is protected by four US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,116,721.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	8,511,304*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	8,746,242*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	11,116,721*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	8,534,281*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	11,116,721*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	8,534,281*PED				Y

Expired US Patents for BREO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	RE44874
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	RE44874
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	7,776,895
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	6,759,398
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	7,629,335
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,776,895
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	5,873,360

International Patents for BREO ELLIPTA

When does loss-of-exclusivity occur for BREO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2075977	INHALATOR TO BE USED TOGETHER WITH MEDICINAL BLOCK
European Patent Office	1534368
Colombia	5310534	NUEVOS DERIVADOS DE ANDROSTANO ANTI-INFLAMATORIOS
China	1066036
Japan	2009502287
African Regional IP Organization (ARIPO)	9100321
World Intellectual Property Organization (WIPO)	03061743

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1305329	300343	Netherlands		300343, 20210803, EXPIRES: 20230110
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1305329	C 2008 007	Romania		PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
1425001	2014C/026	Belgium		PRODUCT NAME: VILANTEROL TRIFENATATE; AUTHORISATION NUMBER AND DATE: EU/1/13/886/001 20131114
1305329	CA 2008 00022	Denmark

Market Dynamics and Financial Trajectory for BREO ELLIPTA

Last updated: February 19, 2026

What is the current market position of BREO ELLIPTA?

BREO ELLIPTA is a combination inhaler approved for the management of asthma and chronic obstructive pulmonary disease (COPD). Manufactured by GlaxoSmithKline (GSK), it commands a significant share in the respiratory drug market. As of 2022, GSK reported that BREO ELLIPTA generated approximately $3.27 billion globally, representing a 15% year-over-year increase. The product's sales are driven by its positioning as a once-daily maintenance therapy preferred by patients for its convenience.

How does BREO ELLIPTA perform financially compared to competitors?

Drug	Therapeutic Area	2022 Revenue (USD)	Market Share (2022)	Key Competitors
BREO ELLIPTA	COPD, Asthma	3.27 billion	20%	Symbicort (AstraZeneca/Bronchitol), Advair (GlaxoSmithKline)
Symbicort	COPD, Asthma	2.84 billion	15%	BREO ELLIPTA
Advair	COPD, Asthma	2.55 billion	12%	BREO ELLIPTA

GSK holds the largest share within the inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination market, with BREO ELLIPTA outpacing certain competitors in sales volume. The product’s revenue growth from 2020 to 2022 shows resilience amid competitive pressures and patent dynamics.

What are the market drivers influencing BREO ELLIPTA's growth?

1. Growing prevalence of COPD and asthma: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) estimates around 200 million COPD cases globally. The World Health Organization (WHO) attributes nearly 4.1 million deaths annually to COPD. Asthma affects almost 262 million people worldwide, with increasing diagnosis rates.

2. Patient preference for convenient dosing: Once-daily formulations like BREO ELLIPTA improve adherence, boosting prescriptions.

3. Broadening geographic access: Expansion into emerging markets, including China, India, and Latin America, supports growth. GSK has increased market access initiatives, resulting in a 10% annual growth rate in developing markets.

4. Pipeline and label expansions: Efforts to secure additional indications, such as COPD exacerbation prevention, bolster revenue streams. GSK seeks FDA approval for a pediatric label expansion, expected in 2024.

What is the impact of patent expiration and generic competition?

BREO ELLIPTA's main patents expire in the U.S. and Europe in 2024 and 2025, respectively. Patent cliffs typically result in revenue declines; however, GSK has implemented strategic measures, including:

• Rapid launch of generic equivalents by competitors, leading to price erosion.
• Introduction of new formulations and delivery devices.
• Expansion into unpatented markets and new therapeutic indications.

The company's projections anticipate a revenue decline of approximately 25-35% in the U.S. market by 2026 due to these factors. Nonetheless, GSK aims to offset losses through growth in emerging markets and pipeline advancements.

How do regulatory policies and reimbursement trends impact BREO ELLIPTA?

Reimbursement policies increasingly favor value-based care, emphasizing medication adherence and long-term outcomes. GSK aligns with these trends by investing in patient support programs. Governments in the U.S. and Europe have introduced price negotiations for respiratory drugs, potentially restricting profit margins.

Notably, the Inflation Reduction Act of 2022 in the U.S. targets drug pricing transparency, which could influence BREO ELLIPTA’s pricing strategies and profitability. GSK’s negotiations with payers have resulted in expanded coverage, partially mitigating pricing pressures.

What is the future financial outlook for BREO ELLIPTA?

GSK forecasts that, despite patent expirations, BREO ELLIPTA will maintain a strong revenue base through:

• International market expansion, particularly in Asia-Pacific.
• Usage growth driven by aging populations.
• Strategic pipeline integration, including new formulations and expanded indications.

Estimated revenues for 2025 are projected to be approximately USD 2.2 billion, down from peak levels but stabilizing due to portfolio diversification and new market entries.

What risks could influence its financial trajectory?

• Competitive erosion post-patent expiry.
• Regulatory delays or restrictions impacting labeling or indications.
• Pricing pressures from health systems and payers.
• Potential emergence of more effective therapies, such as biologics specifically targeting COPD exacerbations or asthma.

Key Takeaways

• BREO ELLIPTA is a leading respiratory inhaler with approximately USD 3.27 billion in global sales in 2022.
• Patent expirations in the upcoming years are expected to induce revenue declines; strategic measures aim to mitigate impact.
• Market growth is driven by increased prevalence, patient adherence, and geographic expansion.
• Regulatory and reimbursement policies exert downward pressure on profit margins.
• Future revenues rely on pipeline development, market expansion, and competitive positioning in the face of patent cliffs.

FAQs

1. When do BREO ELLIPTA patents expire?
   Patent protections in the U.S. expire in 2024, with European patents expiring around 2025.

2. What are the primary competitors to BREO ELLIPTA?
   Symbicort and Advair serve as its main rivals, competing in the ICS/LABA inhaler segment.

3. How does BREO ELLIPTA's adherence profile compare with competitors?
   Once-daily dosing improves adherence relative to twice-daily competitors, potentially leading to better patient outcomes.

4. What strategies does GSK have to sustain revenue post-patent?
   Market expansion, pipeline diversification, device innovations, and indication expansion.

5. How might evolving healthcare policies affect BREO ELLIPTA sales?
   Price negotiations and value-based care policies may exert downward pressure on pricing and reimbursement but also open opportunities for value demonstration.

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References

[1] GSK Annual Report 2022. (2023). GSK.
[2] WHO. (2017). COPD Fact Sheet. World Health Organization.
[3] GOLD. (2023). Global Initiative for Chronic Obstructive Lung Disease Report.
[4] IQVIA. (2023). Global Respiratory Market Analysis.